EMA virtual workshop on myocarditis post COVID-19 vaccination
On 16 January 2023, the EMA hosted a virtual workshop to review the current understanding of the epidemiology, clinical manifestation, and pathophysiology of myocarditis. This is an adverse event that can occur after immunisation with a mRNA COVID-19 vaccine (Spikevax and Comirnaty) or Nuvaxovid, a protein based-vaccine.
The insights and feedback gathered in the meeting are crucial input for a research agenda.
International regulators, academic researchers as well as the marketing authorisation holders for the two approved mRNA COVID-19 vaccines in the EU and for Nuvaxovid shared the available data generated so far and participated in the discussion.
The meeting was divided into two sessions:
- Session 1. Population-based studies and Clinical features of vaccine and infection induced myocarditis
- Session 2. Disease mechanism and molecular findings
Although a number of hypotheses regarding the pathophysiological mechanisms have been put forward, the research data available are extremely scarce and the actual mechanism for the pathogenesis of this adverse event post vaccination is far from being established.
A scientific document summarising the key aspects and the agreed steps to be taken to fill the gaps in the understanding of the aetiology of this disease will be published in due time.
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Agenda - EMA virtual workshop on myocarditis post COVID-19 vaccination (PDF/228.55 KB)
First published: 31/01/2023 -
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Presentation - Global overview of vaccine related myocarditis (Kristine Macartney) (PDF/1.98 MB)
First published: 31/01/2023 -
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Presentation - Risk of myocarditis after Covid-19 mRNA vaccination: Impact of booster dose and dosing interval (Le Vu et al.) (PDF/185.64 KB)
First published: 31/01/2023 -
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Presentation - Incidence, follow-up, and pathophysiology of myocarditis following mRNA vaccine in Israel: Results of an active surveillance (Mevorach) (PDF/10.9 MB)
First published: 31/01/2023 -
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Presentation - Myocarditis after mRNA COVID-19 vaccines in the United States: children aged ≤11 years, and follow-up among people aged 12-29 years at least 90 days after symptom onset of myocarditis (John R. Su) (PDF/896.43 KB)
First published: 31/01/2023 -
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Presentation - COVID-19 Vaccine BNT162b2 myocarditis (Pfizer / BioNTech) (PDF/804.54 KB)
First published: 31/01/2023 -
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Presentation - Moderna COVID-19 vaccines and the risk of myocarditis: review of current data and planned studies (Walter Straus) (PDF/952.81 KB)
First published: 31/01/2023 -
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Presentation - Myocarditis post-marketing reporting rates for Nuvaxovid (Christopher Mast) (PDF/230.36 KB)
First published: 31/01/2023 -
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Presentation - Integrated analysis of transcriptomic and epigenomic signatures of peripheral immune cells in the patient of BNT162b2-induced myocarditis (Bo Kyung Yoon, M.D.) (PDF/1.92 MB)
First published: 31/01/2023 -
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Presentation - Circulating spike protein detected in post-COVID-19 mRNA vaccine myocarditis (Lael M. Yonker et al.) (PDF/1.16 MB)
First published: 31/01/2023 -
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Presentation - Implication of sex differences in myocarditis (Katelyn Bruno) (PDF/3.18 MB)
First published: 31/01/2023 -
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Presentation - Innate immune mechanisms of mRNA vaccines (Rein Verbeke et al.) (PDF/5.37 MB)
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Presentation - IL-RA antibodies in myocarditis after SARS-CoV-2 vaccination (Thurner L et al.) (PDF/4.97 MB)
First published: 31/01/2023 -
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Presentation - Lack of evidence of significant homology of SARS-CoV-2 spike sequences to myocarditis-associated antigens (Alessandro Sette) (PDF/828.38 KB)
First published: 31/01/2023 -
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Presentation - Mechanisms of myocarditis post-COVID vaccination (Alida LP Caforio) (PDF/4.09 MB)
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Presentation - SARS CoV 2 vaccination autopsies (Peter Schirmacher) (PDF/2.41 MB)
First published: 31/01/2023 -
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Presentation - Genetic study of vaccine-induced myocarditis (Alexandre Bolze, Elena Hsieh) (PDF/770.53 KB)
First published: 31/01/2023